Company Quality Policy Statement
It is our mission to maintain the highest level of quality relating to our manufactured products when serving customer needs. At Gibson Bioscience, we will continually seek to improve quality in all areas of the company operation utilizing leading technology and scientific innovation. Our success is directly dependent upon having satisfied customers and superior products manufactured by Current Good Manufacturing Practices.
The Quality System encompasses the processes we have developed to maintain the quality of our products and services in compliance with state and federal regulations.
The facility location used in manufacturing, processing, packaging, and holding of Medical Devices is listed below.
1040 Manchester Street
Lexington, Kentucky 40508
Certifications and Registrations
ISO 13485:2016 (Registration # MD19.8005, The National Standards Authority of Ireland (NSAI))
- Represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices.
- The principal standard for manufacturers of medical products, devices and components.
- A testament to the manufacturer's quality management system and their ability to consistently design, develop, produce and distribute in-vitro microorganism preparations of the highest quality.
ISO Certification assures customers that Gibson Bioscience provides services and manufactures product in accordance with a sound Quality Management System.
Food and Drug Administration Establishment (Registration #: 1050138)
- Applies to the facility, methods and controls used for the design, purchase, manufacture, packaging, labeling, storage and distribution of in-vitro medical diagnostic products.
- Ensures that finished products are safe, effective and in compliance with Federal Food and Drug and Cosmetic Act.
Registration with the FDA provides evidence that Gibson Bioscience adheres to all Current Good Manufacturing Practices (CGMP.)